Barrett's esophagus esophageal cancer
Conditions
Interventions
Endoscopic balloon based cryoablation. The C2 Cryoballoon 180 Ablation system
has three main components: a delivery catheter with a spray-hole covered by a
balloon probe, a controller and a cartridg
Sponsors
C2 Therapeutics, contactpersoon Marcia Wachna
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must meet ALL of the following criteria to be eligible for participation in the study: 1. Flat- type BE esophagus, with an indication for ablation therapy, defined as: a. Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR b. Residual BE with any grade of dysplasia after endoscopic resection (EMR or ESD) to treat non-flat BE, *6 weeks prior to enrolling the patient to this study. The ER pathology should indicate endoscopic treatment (i.e. only mucosal invasion or limited submucosal invasion (SM1), no lymphovascular infiltration, free vertical resection margins and not poorly differentiated) 2. Prague Classification Score C*3 and *M1 3. Patients should be ablation-naïve, meaning they have not undergone any previous ablation therapy of the esophagus 4. Older than 18 years of age at time of consent 5. Operable per institution*s standards 6. Provides written informed consent on the IRB-approved informed consent form 7. Willing and able to comply with follow-up requirements
Exclusion criteria
Exclusion criteria: 1. Esophageal stenosis preventing advancement of a therapeutic endoscope. 2. Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER >6 weeks prior to planned treatment under this protocol. 3. Prior ER of more than 2cm in length or >50% of the esophageal lumen circumference 4. History of locally advanced (>SM1) esophageal cancer 5. History of esophageal varices 6. Prior distal esophagectomy 7. Active esophagitis LA grade B or higher 8. Severe medical comorbidities precluding endoscopy 9. Uncontrolled coagulopathy 10. Pregnant or planning to become pregnant during period of study 11. Patient refuses or is unable to provide written informed consent 12. Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study 13. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Feasibility, defined as the number of procedures with treatment success (all BE treated as intended by the endoscopist) * Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (0-10 VAS score) at 24 hours AND 7 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD. Any other serious adverse events within 30 days after treatment will be evaluated by DSMB for relationship to the dose and severity. * Dose response (efficacy) is defined as eradication percentage of BE confirmed by histological evidence of eradication of BE, after circumferential treatment with the therapeutic dose (phase II). The eradication percentage will be assessed by the EGD-Adjudication Committee (EGD-AC), consisting of three physicians specialized in gastroenterology, by comparing pre-treatment and follow-up digital images of the ablated areas in a systematic and standardized manner. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Post-procedure pain in the treatment area from the cryoablation treatment (VAS 0-10), described as the median pain scores directly and 1, 7 and 30 days after treatment. 2. Post-procedure dysphagia (0-4 dysphagia score), described as the median dysphagia scores directly, 1, 7 and 30 days after treatment. 3. Incidence of all serious and non-serious adverse events up to 30 days post-treatment 4. Efficacy, defined as the percentage of patients with histopathological confirmed complete eradication of BE and absence of subsquamous intestinal metaplasia. | — |
Countries
Netherlands
Outcome results
None listed